Part One: Healthcare's Normalization of Deviance and Covid-19

Back on February 9th of this year, just a few weeks after the WA state Covid-19 deaths began to surface, Joe Rogan had astronaut Garrett Reisman on his amazing podcast series. During that podcast Garret shared a great many things about spaceflight and technologies for both manned and unmanned spaceflight, but as an anesthesia provider of 17 years, and of course a medical device business owner, one of my favorite topics he discussed was on the subject “Normalization of Deviance.” 

The Wikipedia definition is as follows:

Normalization of deviance is a term used by the American sociologist Diane Vaughan to describe the process in which deviance from normal behavior becomes normalized in a corporate culture.

Vaughan defines this as a process where a clearly unsafe practice comes to be considered normal if it does not immediately cause a catastrophe: "a long incubation period [before a final disaster] with early warning signs that were either misinterpreted, ignored or missed completely.

The original example cited by Vaughn was the events leading to the Challenger disaster, but the concept has also been applied to clinical practice in medicine and aviation safety.

Garrett’s discussion, at the 1 hr. 24 second mark of the podcast, centered around the Columbia shuttle disaster. He explained how the fuel tanks required for launching were always known to shed off foam and ice debris during launch, and how those projectile pieces could potentially hit or damage the very critical heat shields required for reentry.

In the early days, the potential for structural integrity failures from this phenomenon were always treated with urgency, they would even demand certain flight maneuvers to check hull integrity, but over the years there was a cultural acceptance of a normal deviation from historical standards of practice, as the odds of failure never manifested in reality. With that said, he discussed how a culture, even a rigid culture like NASA’s, gets away with something until all the right conditions align to create a catastrophic event, and much like the disaster that killed seven crew members, that is where we find ourselves today with COVID-19.

Reducing and recognizing a culture of “Normalization of Deviance” is the basis for evolving military and aviation practices over the past several decades, as these entities focused on creating a culture of highly reliable processes, algorithmic trouble shooting, and delineation of responsibilities during a crisis. These organizations also used non punitive ways to recognize human error through self reporting and primary internal investigations and then correct it, so it would not be repeated. This is the hallmark of highly reliable organizations (HROs), and it’s something I write about quite a lot. In aviation this process is called Crew Resource Management (CRM). This kind of accountable cultural shift is is desperately needed in healthcare.

In fact, before the airline’s adoption of CRM, most aviation mishaps were due to cultural practices that failed to keep the plain flying, as they all focused on a singular problem or event, while forgetting to appoint a person to maintain safe flight. It was found that most flight errors were human in nature. What they learned from historical fact finding was there were ways to improve and drive human and design processes needed to support safety and standardization. Above all, these cultural practices are meant to assure accountability, and as we will find after the dust of this crisis settles, there is and has always been little accountability in healthcare.

Why This Matters

Over the last two decades of practicing anesthesia, I have personally witnessed a healthcare culture hell bent and focused on the cost of things, rather than the performance, the efficacy, and the safety of the services it was designed to provide. 

This declaration is not meant to undermine the inherent good we provide as a business, as there are a great deal of people working hard every day, but it serves as a call for self reflection and opportunities to improve it. This cultural acceptance not only had an impact on patient care, it had an impact on the safety of those providing that care. Lean measures understaffed hospital floors, overworking the staff needed to perform care, and a series of blind line item cost reductions reduced their choices in having the right equipment and services needed to keep them and their patient’s safe, all while others were incentivized through profit and bonus schemes to make the “numbers” always look good on a spreadsheet. Healthcare is dynamic, it can't be treated as a commodity, and neither can its processes.

As we continue to hear stories of our fellow care providers on the front line, who up until recently were culturally indoctrinated to always ask “How Much?”, or forced to silently rely on their own resourcefulness secondary to a lack of goods and services needed to improve their care and safety, the truth and failure of our current business model is obvious. 

Supply chains and administrators then took silent acceptance for submission and provider compliance. If they didn’t hear complaining, they assumed they had no problems. As a company we heard this all the time from supply chain representatives and administrators. Dissenters would either be silenced, or reprimanded, while other colleagues mumbled under their masks and toiled with the daily acceptance of “This is the way we have always done it.” They felt helpless. Healthcare providers soon lost the power of advocacy and respect they once had under this new model of “VALUE BASED CARE.”

Who Do We Blame?

The healthcare industry is not inherently evil, and not everyone is a crook or in it for themselves, but we must all accept some culpability when it comes to how it got to this point. All of us.

Most of it was due to a lack of advocacy, a lack of listening, and decision making made by people who have no idea what’s its like to care for others, risk their safety to care for others, or give all they have as people with humility and grace in the service of others. For supply chain and administrators, it’s not inherently their fault either, for they have been tasked and incentivized with one goal, and one goal only, to reduce line item costs and improve operational efficiencies that improve the business of their facilities. It's important they too understand the impact of their decisions for those on the front lines. Look, we are all incentivized and rewarded for our part, but we must understand the symbiotic relationship to others in the healthcare chain.

Perhaps this is all due to the increasingly rigid compartmentalization between departments, one problem that can be refined after this disaster blows over. Perhaps we gave too much sway to other middlemen, or decision makers thousands of miles away, who were feeding us information we thought was credible, making supply and sourcing decisions for us, while extorting fees from manufactures and companies, picking, steering, and choosing winners and losers for the profits they would make with every order through chosen suppliers.

Perhaps it's because so many healthcare CEOs are on the boards of these GPO and PBM organizations, which is a huge conflict of interest. Maybe it’s the lack of transparencies and free markets needed to improve healthcare we are missing under the current business model. One thing for sure, under this model, these companies only sourced from limited suppliers with no back up in the event of a global disruption in supply chain. Perhaps we just need a blockchain of transparent souring of goods and sources to destroy the dynamic sourcing model. So this is where we find ourselves.

Cultures After the ACA

When the ACA was passed, many small practices and provider groups ran for cover into the arms of huge corporate entities, for-profit and non-profits alike. The hope was that this would improve the cost and delivery of care.

Many small groups struggled to exist, as referrals were steered to others, and the overhead cost of healthcare grew to astronomical rates. In fact, despite the ACA, has anyone ever asked why the cost of care continues to increase? Business 101, it’s overhead.

Before this chaos, healthcare GDP was 17.9%, or $3.6 trillion. It’s expected to rise to $6 Trillion by 2027. Administrative overhead contributed $1.1 trillion of that cost in 2017. This administrative burden continues to rise. The current crisis will blow up this dire predictive GDP model in terms of human and taxpayer cost burden for generations to come. None of this is sustainable without self regulation. This industry does not want enhanced government regulations, so it is up to us all.

When you couple this with supply chain strategies that never planned for a backup or purchasing steering from oligarchies and monopsonies like GPOs and PBMs, we found our industry with a lack of transparency, choices, or a free market system we needed to actually improve cost. Those middle entities exploited manufactures for fees they could legally take from us through “Safe Harbors”, given to them by our federal government, a Carte Blanche that other businesses, and even the mafia, would be charged for under federal racketeering and RICO statutes on any given day. They picked the winners and losers in boardrooms that profited them, while telling the rest of healthcare they got a good deal under an unenforceable and murky “contract”. Yes, it is true, no GPO contract truly exists. It’s a pervasive myth that limits choices. In fact, a great deal of nonprofit and for-profit hospital administrators and CEOs sit on these boards. If you go to the FAQs at the Healthcare Supply Chain Association’s Website, you’ll find proof of this statement.

Are hospitals and suppliers required to use GPOs?

“No. All GPO contracts are voluntary and the product of competitive market negotiations. Suppliers are not required to contract with GPOs and healthcare providers are not required to use the contracts negotiated by GPOs with suppliers, even if the providers were a part of the committee process that reviewed and approved the contracts. All hospitals, nursing homes, clinics, surgery centers, etc., can purchase “off contract” and often do. Virtually all of America’s 7,000+ hospitals as well the vast majority of the 68,000 non-acute care centers belong to at least one GPO. A 2010 GAO report found that, on average, hospitals belong to 2-4 GPOs, which compete with one another for hospital business”

We got so focused on the cost of goods and services as a means to reduce the rising cost of healthcare, while accepting the exploitation of accreditation organizations, GPOs, PBMs, and the rising bloat of administration, that we never stopped to ask ourselves how we could make it better on the front lines, and to our patients. 

Loss of Manufacturing Sovereignty

Another key impact to this fiasco, was of course the loss of US manufacturing sovereignty. Society got so used to consumer driven commoditization of goods and cheap pricing, that we failed to understand the impact of it suddenly going away. Americans will soon find that almost all of healthcare goods and drugs are made in China. 

Rest assured, this is not a rant against China, as we all depend on a global market of goods, but you have to ask yourself, if your country (as ours is right now) were going through a healthcare crisis, would you divert your nation’s manufacturing of much needed goods to your own countrymen first? Of course you would. The irony here, is if we were better prepared from a domestic manufacturing perspective, we would have the ability to help not just us, but others in need.

No, China is not inherently evil, but they do what is required of them when they are under duress, it’s just that we don’t have a way to proportionally respond on our side as it relates to manufacturing domestically. We gave them rights away for profits and margins, along with a dependence on cheap goods, without understanding the security we were given up in times of scarcity. This is an inflection point for America and healthcare. This is just supply chain crisis, could you imagine the impact if we had trade or geopolitical issues with the only country that makes over 90% of our goods and drugs? Here’s a sobering article to shed light on how dependent we are on China for goods, especially pharma: https://blog.riskmanagers.us/china-can-shut-down-u-s-pharmacies-hospitals-in-months/

PPE and Caregivers

In the news we have seen the impact a lack of resources can have for those on the front lines. It’s a sure bet that after all of this settles down, there series of class action lawsuits against healthcare facilities and their administrators, the CDC, and perhaps the federal government. Personally, would love to see all those exploitative middlemen also sued for not having a diversified supply chain backup. You see, like “Normalization of Deviance”, it all works until it doesn’t. Everyone had their hand in cookie jar when times were great, at the expense of caregivers, patients, and even third-party payers.

The audacity that we could be fined two months ago for wearing a surgical mask in the hall, or a wearing a gown during transportation of contaminated patients, could then suddenly be acceptable in a crisis, goes against the legitimacy for any regulating body ever to exist. The fact that the CDC would advocate using a bandanna as a back-up, goes against everything we ever learned about airborne contagions and clinical practice. I personally feel they relaxed restrictions to reduce the number of lawsuits targeted against healthcare conglomerates by their staff during and after this crisis, releasing any culpability they had for not being prepared, as they could point to changes in CDC, NIOSH, OSHA, and other previous and evolving requirements and recommendations.

Stay Tuned For Part 2!

About the author: David is an CRNA anesthesia healthcare provider, a Veteran, and the CEO of infinitusmedical.com. IMT is a company made up of military members with CRM experience, clinical experience, and OSHA experience. Highly reliable processes were always a key part of our product development. We sought to design products that facilitated standardized behaviors, instead of relying of resourcefulness and variance. This serves to create to improve the safety of patients and providers!